In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. This is done using simple text files called cookies which sit on your computer. By continuing to use this site and access its features, you are consenting to our use of cookies. To find out more about the way Informa uses cookies please go to our Cookie Policy page.

Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say

Analysis

Executive Summary

The FDA Reauthorization Act, enacted last month, includes provisions that aim to improve FDA's inspection process, including putting a stop to arbitrary audit scheduling by the agency – a practice that can cause a facility inspection to drag on for weeks at a time. FDA has until early 2019 to draft a guidance document that lays out how it will ensure a more uniform inspection process that ensures greater parity between foreign and domestic audits. Steps mandated by the new law include notifying firms in advance of records that will be requested during an inspection and specifying a window of time for investigators to conduct the onsite inspections. But industry experts are of two minds as to whether any substantial changes will result from the new law. Also: FDA device center Director Jeff Shuren weighs in.